Efforts to improve the standard of insulin therapy have been driven largely by consideration of the needs of the affluent, western diabetic patient. Substantial improvements have been realized in optimized glucose control, with the introduction of prandial and basal insulin analogs as well as basal/bolus insulin mixtures. Increased convenience and compliance has been achieved through the introduction of insulin pens and electronically controlled pumps. In addition, recent attempts have been made to offer alternatives to subcutaneous injection through the development of pulmonary delivery systems.
While noteworthy, these advances have left the more fundamental and urgent needs of the developing world patients largely unmet. As epidemiological trends suggest, it is the developing world diabetic population that is experiencing the most rapid growth. Chief among the problems facing this population is the limited stability of the conventional insulin preparations. Package inserts typically recommend storing unopened vials at 2° C. to 8° C. and discarding vials 28 days after opening. While this limitation rarely poses problems for western populations, it does impose hardships for users in developing countries where access to refrigeration is limited and temperatures may exceed 25° C. for extended periods of time. The needs of these patients need to be addressed with meaningful advances certain to have an impact from both an economic and humanitarian standpoint. Additionally, a more stable insulin with a reduced tendency toward fibrillation would be well suited for use in pumps and similar infusion devices where clogging problems can be a hazard.